Independence Blue Cross (IBX) provides coverage for drugs, biologics, and gene therapies that have received FDA-accelerated approval when research findings demonstrate direct evidence of their clinical effectiveness.
Starting January 1, 2025, IBX is clarifying its continued non-coverage position for certain drugs, biologics, and gene therapies that have received FDA-accelerated approval without demonstrating clinical findings that show effectiveness. In these cases, it is typical for the FDA to require continued research studies to demonstrate clinical effectiveness and proven safety of the treatment.
IBX's position is effective for a period of 18 months after the FDA accelerated approval date to allow time for the confirmatory trials directed by the FDA. We will continue to review evolving data to inform our benefit position during this time. As outlined in our medical policy that addresses Coverage of Routine Costs Associated with Qualifying Clinical Trials, IBX will continue to support our members by covering their routine costs when associated with a qualifying clinical trial.
Anti-cancer treatments are not included and remain a covered benefit for IBX members.
Please note that due to the continued lack of a demonstration of clinical effectiveness, the following drugs are not covered:
- Monoclonal antibodies directed against amyloid for the treatment of Alzheimer's disease
- Delandistrogene moxeparvovec (Elevidys)
- Tofersen (Qalsody®)
- Exon skipping drugs for Duchenne Muscular Dystrophy
What this means for your patients (our members):
If your patient currently receives an affected drug, biologic, or gene therapy, they are responsible for the full cost.
Impacted members may use their Health Savings Account (HSA) or Flexible Spending Arrangement (FSA) dollars, if eligible.
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